Speclips (CEO Jeong-Hwan Hong), a company specializing in laser and artificial intelligence (AI)-based skin treatment and skin cancer diagnosis, announced on the 26th that its laser-based skin beauty and treatment devices, PICO-K and BELLUS-Q, have received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
Pico-K is a fourth-generation picosecond laser medical device specialized in pigment treatment. Based on nine patented technologies, it has been recognized for its stability and precision. It improves on the uneven beam issues of existing picosecond lasers, maintains high energy density, and delivers superior transmission. The BellusQ, a nanosecond laser, has proven its quality and functionality in the existing nanosecond laser market.
With this FDA approval, Speclipse has advanced its US market entry by a quarter ahead of schedule, allowing it to fully reflect its local performance this year. To achieve this, Speclipse has signed distribution and marketing partnerships with global aesthetic companies and has set a sales target of at least 10 billion won in the US market this year. Orders for the first quarter have been completed, securing approximately 3 billion won in sales.
Hong Jeong-hwan, CEO of Speclipse, stated, "We were able to quickly obtain FDA approval thanks to the technological prowess of Pico-K and BelusQ and our global regulatory capabilities. With the launch of local sales in the US, we expect to enhance our global credibility and contribute to our performance growth this year." He added, "With the increasing number of papers and clinical trials demonstrating our product's safety and efficacy, we will expand our marketing efforts to healthcare professionals to pioneer new markets."
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